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Ocella

Last reviewed on RxList: 3/25/2020
Ocella Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ocella?

Ocella (drospirenone and ethinyl estradiol kit) is a combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.

What Are Side Effects of Ocella?

Side effects of Ocella include:

Dosage for Ocella

The dose of Ocella is one tablet taken by mouth at the same time every day. To achieve maximum contraceptive effectiveness, Ocella must be taken as directed, in the order directed on the blister pack.

Ocella In Children

Safety and efficacy of Ocella has been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Ocella?

Ocella may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Ocella During Pregnancy and Breastfeeding

Ocella is intended to prevent pregnancy and is not indicated for use during pregnancy. There is little or no increased risk of birth defects in women who inadvertently use combined oral contraceptive (COCs) during early pregnancy. Women who do not breastfeed may start COCs no earlier than four to six weeks postpartum. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. Estrogen-containing COCs such as Ocella can reduce milk production in breastfeeding mothers. Nursing mothers are advised when possible to use other forms of contraception until they have weaned their children. Consult your doctor before breastfeeding.

Additional Information

Our Ocella (drospirenone and ethinyl estradiol kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Ocella Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • a change in the pattern or severity of migraine headaches; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • headache, mood changes, feeling tired or irritable;
  • weight gain; or
  • changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ocella (Drospirenone/ethinyl Estradiol Tablets, for Oral Use)

QUESTION

Which of the following are methods for contraception? See Answer
Ocella Professional Information

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

  • Serious cardiovascular events and stroke [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Vascular events [see WARNINGS AND PRECAUTIONS]
  • Liver disease [see WARNINGS AND PRECAUTIONS]

Adverse reactions commonly reported by COC users are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

The data provided reflect the experience with the use of OCELLA (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18 -35 who were treated for up to 13 cycles. The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of OCELLA vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17-40 who were treated for up to 26 cycles.

The most common adverse reactions (≥ 2% of users) were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%) abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%).

Adverse Reactions (≥ 1%) Leading To Study Discontinuation

Of 2,837 women, 6.7% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was headache/migraine (1.5%).

Serious Adverse Reactions

Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of OCELLA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.

Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension

Hepatobiliary disorders: Gallbladder disease

Immune system disorders: Hypersensitivity

Metabolism and nutrition disorders: Hyperkalemia

Skin and subcutaneous tissue disorders: Chloasma

Read the entire FDA prescribing information for Ocella (Drospirenone/ethinyl Estradiol Tablets, for Oral Use)

Related Resources for Ocella

© Ocella Patient Information is supplied by Cerner Multum, Inc. and Ocella Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow

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